Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia
Status unconfirmed · Not applicable
Conditions studied: Insomnia
In brief
Insomnia is a common medical condition that has a deleterious effect on emotional status, health-related quality of life, and has been associated with hospitalizations and all-cause mortality. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the comfort of their homes via the wireless iPAD and video chat software. In patients who are recently discharged from the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services is an important area of future research.
Key facts
- Study ID
- NCT03267537
- Run by
- University of Arizona
- People needed
- 74
- Starts
- 2017-06-13
- Expected to finish
- 2019-05-31
- Last updated by the study team
- 2017-09-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Medically ill patients with recent hospitalization who are being discharged to home.
- ISI score of > 10 (chronic insomnia)
- Age > 18 years
- Ability to provide informed consent
- Willingness to undergo sleep study
You may not qualify if…
- Presence of untreated sleep disorder that requires treatment independent of insomnia (Narcolepsy, restless leg syndrome, or REM sleep behavior disorder)
- Patients with severe debilitating neurological disease (end-stage Alzheimer's, large stroke, or other debilitating neurological disease) or any other condition that renders patients incapable of providing informed consent
- History of Bipolar disease; current or past (< 6 months) history of suicidality or suicidal ideation
- Active substance abuse or alcoholism
- Pregnancy or lactation
Where it is running
- University of Arizona (Banner University Medical Center - Tucson & Banner University Medical Center - South) — Tucson, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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